BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENITOURINARY SPHINCTER ARTIFICIAL CUFF

    MDR report key: 1012991 · Received February 19, 2008

    Report

    Report Number
    1012991
    Event Type
    Malfunction
    Date Received
    February 19, 2008
    Date of Event
    January 21, 2008
    Report Date
    February 18, 2008
    Manufacturer
    AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    EZY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    SUSPECTED FAILURE OF ARTIFICIAL CUFF. PIN-HOLE LEAK FOUND IN CUFF WHICH REQUIRED REPLACEMENT OF HYDRAULIC FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENITOURINARY SPHINCTER ARTIFICIAL CUFF CUFF, ARTIFICIAL SPHINCTER EZY AMERICAN MEDICAL SYSTEMS, INC. NA 399141004

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR